Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Digestive System Diseases

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Gland and Hormone Related Diseases

Rare Diseases

Uterine Cervical Neoplasms

Esophageal Neoplasms

Carcinoma

Cholangiocarcinoma

Breast Neoplasms

Adenocarcinoma

Melanoma

Carcinoma, Non-Small-Cell Lung

Stomach Neoplasms

Glioblastoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Carcinoma, Renal Cell

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Mesothelioma

Mesothelioma, Malignant

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Head and Neck Neoplasms

Adenoma

Neoplasms, Mesothelial

Esophageal Cancer

Ovarian Cancer

Bile Duct Cancer

Renal Cell Carcinoma

Stomach Cancer

Ovarian Epithelial Cancer

Clear Cell Renal Cell Carcinoma

Malignant Mesothelioma

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Drug: NGM707

NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated.

NGM707

Drug: NGM707

NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated.

Drug: pembrolizumab

Pembrolizumab will be administered intravenously (IV) every 3 weeks in a 21 day cycle.

NGM707 plus pembrolizumab

Drug: NGM707

Preliminary recommended phase 2 dose (RP2D) of NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle.

Drug: NGM707

Preliminary recommended phase 2 dose (RP2D) of NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle.

Drug: pembrolizumab

Pembrolizumab will be administered intravenously (IV) every 3 weeks in a 21 day cycle.

NGM Medical Director

NGM Site 004

NGM Site 016

NGM Site 010

NGM Site 008

NGM Site 009

NGM Site 007

NGM Site 014

NGM Site 003

NGM Site 012

NGM Site 013

NGM Site 006

NGM Site 001

NGM Site 002

NGM Site 200

NGM Site 201

NGM Site 252

NGM Site 250

Study of NGM707 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies

Study of NGM707 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies

A Phase 1/2 Dose Escalation/Expansion Study of NGM707 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies

A DLT is defined as an AE that meets at least one of the criteria listed in protocol, according to National Cancer Institute (NCI) common terminology criteria for AE (CTCAE) version 5.0, and is considered by the investigator to be clinically relevant and attributed to the study treatment during the first 28 days after the first dose of study treatment.

Number of patients with adverse events (AEs) according to severity, seriousness, and relationship to study drug

An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of patients who experience at least one AE will be presented.

Number of patients with clinically significant change from baseline in laboratory abnormalities as characterized by type, frequency, severity (graded by CTCAE version 5.0) and timing.

Objective Response Rate is defined as the proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1

Duration of Response is defined as the time from the first documentation of objective response (CR or PR) that is subsequently confirmed per RECIST v1.1, to the time of the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.

Progression-free survival is defined as the time from start of study treatment to the date of first documentation of objective tumor progression on or following study therapy per RECIST v1.1, or to death due to any cause, whichever comes first.

Overall survival is defined as the date from start of the study treatment to the date of death due to any cause.

Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycle 4 and each cycle thereafter.

Area under the curve from time zero extrapolated to the last quantifiable dose of NGM707. Time zero extrapolated to the last quantifiable time point prior to the next dose. Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycle 4 and each cycle thereafter.

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycle 4 and each cycle thereafter.

Incidence and titers of anti-drug antibodies (ADA) against NGM707. Will be measured on Day 1 of each cycle.

Merck Sharp & Dohme LLC

NGM Biopharmaceuticals, Inc

VR distraction occurring visits 1 and 2 with normal SOC therapy at visits 3 and 4.

VR distraction occurring visits 1 and 4 with normal SOC therapy at visits 2 and 3.

VR distraction occurring visits 3 and 4 with normal SOC therapy at visits 1 and 2.

VR distraction occurring visits 2 and 3 with normal SOC therapy at visits 3 and 4.

The hardware includes the wireless headset with integrated headphones which will block the sight and sounds of the clinical setting as well as the hand controllers for the interactive VR experience, which will be delivered through any of three VR software options (subject may choose one or more from the following options):

* Titans of Space® PLUS developed by Drash VR, LLC (Murrieta, CA, USA)
* TRIPP® developed by TRIPP, Inc. (Los Angeles, CA, USA)
* Nature Treks VR published by Greener Games (Ironbridge, England, UK)

The Oculus Quest 2 Virtual Reality Headset

Joseph A Holley

Matthew R Kovak

Gary Lewis, MD

The primary objective is to demonstrate the feasibility of incorporating VR distraction into the brachytherapy and radiotherapy clinical workflow.

The secondary objective is to determine if VR distraction during brachytherapy treatment for cervical cancer improves subjects' satisfaction, procedural/acute pain, and need for analgesics or anxiolytics.

This will be a prospective pilot study conducted at UAMS. All subjects will experience VR distraction using a crossover design in which each subject receives four rounds of brachytherapy: two rounds with VR distraction and two rounds without VR distraction. Brachytherapy will be conducted per SoC workflow. Subjects will be placed into four treatment-sequence groups in a 1:1:1:1 allocation ratio via permuted block randomization with randomized block sizes of four or eight.

The four treatment-sequence groups will follow the four-session treatment schedules outlined below, in which "V" denotes the sessions when VR distraction is used while "N" denotes the sessions when it is not:

* Sequence Group A will be treated according to schedule VVNN.
* Sequence Group B will be treated according to schedule VNNV.
* Sequence Group C will be treated according to schedule NNVV.
* Sequence Group D will be treated according to schedule NVVN.

Subjects will be placed into four treatment-sequence groups in a 1:1:1:1 allocation ratio via permuted block randomization with randomized block sizes of four or eight.

Using Virtual Reality Technology to Improve Patient Experience and Quality of Care During Brachytherapy

Compare the subject's procedural pain scores (using a visual analog scale \[VAS\] pre- and post-procedure) between sessions with VR and sessions without VR.

Compare the subject's procedural anxiety scores (using a VAS pre- and post-procedure) between sessions with VR and sessions without VR.

Compare the dose(s) of opioid pain medication per session (using morphine milligram equivalents \[MMEs\]) between sessions with VR and sessions without VR.

Compare the dose(s) of benzodiazepine anxiolytics per session (using a benzodiazepine conversion calculator) between sessions with VR and sessions without VR

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of NGM707 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies	NCT04913337	Mesothelioma Glioblastoma Renal Cell Carc... Non Small Cell ... Melanoma Pancreatic Duct... Gastric Cancer Squamous Cell C... Cholangiocarcin... Breast Cancer Ovarian Cancer Cervical Cancer Endocervical Ca... Colorectal Canc... Esophageal Canc...	NGM707 NGM707 plus pem... NGM707 NGM707 NGM707 NGM707 plus pem... NGM707 plus pem...	18 Years -	NGM Biopharmaceuticals, Inc
Using Virtual Reality Technology to Improve Patient Experience and Quality of Care During Brachytherapy	NCT05440760	Endocervical Ca...	The Oculus Ques...	18 Years -	University of Arkansas

Spots Global Cancer Trial Database for endocervical cancer